ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)

Recent survey results show that the pharmaceutical companies often take an overly conservative approach to NIMPs (or Non-IMPs) due to regulatory and operational ambiguity. This can lead to unnecessary expenses and process steps, which can needlessly complicate clinical trials.

The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) aims to provide practical operational guidance and drive a consistent industry approach to the use of NIMPs. The Guide contains criteria for classifying NIMPs and an overview of current NIMP regulatory requirements.

This in-depth Guide will help you properly manage NIMPs by providing guidance on:

• Sourcing strategies
• Packaging and labeling approaches
• Storage and distribution recommendations
• Regulations categorized by region/country
• Approaches to management of drug accountability, traceability, complaints and recalls with reference to the original sourcing strategy
• Regulatory differences between NIMPs and comparators

Product Details

Published:

01/01/2013

ISBN(s):

9781936379576

Number of Pages:

56

File Size:

1 file , 2.1 MB